The instant invention employs surfactants to enhance the pharmaceutical elegance of reconstituted solutions of pharmaceutical powders stored in plastic containers. The enhancement afforded by the instant process and composition is achieved whether the powder is to be reconstituted in the plastic container or the powder is to be removed from the plastic container then reconstituted. A preferred embodiment of the invention encompasses parenteral pharmaceutical compounds in powder form stored in plastic containers.
Additives, impurities, and monomers and oligomers will often migrate from the plastic container onto the pharmaceutical powder stored therein. Examples of substances that can migrate from the plastic onto the powder include mold release, anti-slip, anti-static and anti-oxidant agents, plasticizers, coloring agents, primers, heat-sealable coatings, machineability coatings, and barrier coatings, etc.
The migrating components form an emulsion that appears as "haze" when the pharmaceutical powder is reconstituted. The haze may be visible while the solution is in the plastic container and is visible when the reconstituted solution is placed in a glass container for inspection. The presence of haze may cause the observer to reject the solution as unsuitable for administration even though the solution is not necessarily harmful to the patient.
The packaging and storage of pharmaceutical powders in plastic containers, especially pharmaceutical powders that are to be reconstituted for parenteral administration, is known. For instance, two antibiotics, cefazolin sodium and cephalothin sodium, are stored in reconstitutible powder form in flexible plastic bags.
The use of surfactants to solubilize pharmaceutical compounds has been described in articles such as J. Pharm. Sci., 54:9, 1229 (1965). However, the above reference does not teach a method to reduce or eliminate the haze caused by the migration of components and contaminants of the plastic container onto the pharmaceutical compound in powder form.